Preparations would help make doses rapidly if testing pans out, but companies risk large outlays if the research doesn’t succeed
Drugmakers are reconfiguring manufacturing plants and hiring hundreds of new workers to be ready to make coronavirus drugs and vaccines should they prove in testing to be effective in fighting off the virus.
Johnson & Johnson, JNJ 1.97% Pfizer Inc. PFE 2.70% and other companies are gearing up so they can make hundreds of millions of doses of coronavirus pills and shots as quickly as possible if studies support their worth.
For some companies, the efforts involve shifting production of existing drugs to other factories, rejiggering supply chains and even partnering with rivals.
Companies, which typically only make enough doses of developmental drugs for studies, don’t usually start readying for full-scale production this early. This manufacturing ramp-up, however, is part of the industry’s speedy mobilization to deal with the pandemic even as companies lose out on tens of millions of dollars in manufacturing investments if their drug and vaccine candidates fail during testing.
Regeneron Pharmaceuticals Inc. plans to shift production of eye-disease treatment Eylea and other drugs to facilities in Ireland to devote its Rensselaer, N.Y., plant to making a Covid-19 drug.
“By the end of the summer, I’d like our plant to be completely operational to produce large quantities” of a coronavirus drug, Regeneron Chief Executive Leonard Schleifer said in an interview, “and not far behind that, to have other companies using our technology to make sure we can supply as many people as possible.”
There is no approved treatment or vaccine for Covid-19, the disease caused by the virus. Drugmakers and public-health officials are hoping a drug to treat symptoms of the disease could clear testing and be greenlighted for widespread use within months, and a vaccine by early 2021.
To be ready to make large volumes of the products, companies must begin preparing their plants now. They need to secure supply chains for key ingredients—sometimes from other countries—install new equipment, and find contract manufacturers who can help.
Gilead Sciences Inc. began ramping up manufacturing of its experimental antiviral drug remdesivir in January, when researchers began exploring its use against Covid-19. As of late March, the drugmaker had produced more than 30,000 treatment courses.
Gilead aims to have produced 140,000 treatment courses for Covid-19 patients by the end of May, and more than one million by the end of December, though the company is still waiting for the results of testing.
In a pandemic, “you can’t wait to start making your investment in the manufacturing until you’re sure you have a product,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute, which promotes vaccine adoption and trains immunization professionals.
Preparing manufacturing plants to make a new vaccine can cost anywhere from $50 million to $700 million, according to a 2017 paper in the medical journal Vaccine.
To reduce the risk of squandering the investment, pharmaceutical companies typically wait until a drug or vaccine is in the advanced stages of testing, and looks like it will succeed in the studies, before starting to make it in large quantities.
But the unpredictable nature of pandemics has wound up costing drugmakers in previous outbreaks of viruses like Ebola, which subsided before drugs finished testing and companies could start selling them.
Drugmakers would likely have a big market for products that are successful in clinical trials, but profits may be limited because some companies have said they’ll sell on a not-for-profit basis at affordable prices.
Now, governments and nonprofits are trying to help companies reduce their financial risks, and companies are putting their hands out for financial assistance.
“We cannot produce all of this and not know if there’s going to be a market or not, or if it is going to work or not,” said David Loew, who leads Sanofi SA’s vaccine business, one of the world’s biggest.
He said Sanofi is talking with governments and nonprofits about getting financial help to pay for making hundreds of millions of doses of its coronavirus vaccine candidate.
The Bill and Melinda Gates Foundation said last week it plans to work with governments and other organizations to help finance the expansion of vaccine production to expedite a global supply once clinical trial results are available.
The U.S. Biomedical Advanced Research and Development Authority recently agreed to give Moderna Inc. up to $483 million partly to pay for scaling up capabilities to make the biotech’s coronavirus vaccine candidate, one of the most advanced.
The new federal funding will help the company develop processes for large-scale manufacturing of tens of millions of doses a month next year, Chief Executive Stephane Bancel said.
Moderna, which has about 850 employees, plans to hire another 150 by the end of the year to help with the manufacturing ramp-up, Mr. Bancel said. The company will expand manufacturing to three shifts a day, seven days a week, from two daily shifts each weekday.
J&J aims to make more than one billion doses of its experimental vaccine, Chief Scientific Officer Paul Stoffels said. It will start making the shots soon at a plant in Leiden, the Netherlands, which has been making experimental vaccines for other diseases.
The company plans to produce the vaccine at plants in the U.S., Dr. Stoffels said, and is talking with contract manufacturers that could make it in Europe and Asia.
Pfizer aims to begin testing four vaccine candidates in development with Germany’s BioNTech SE by the end of this month. Pfizer has been buying raw materials to make the vaccines and plans to tap manufacturing plants that make sterile injectable products or vaccines such as its pneumococcal vaccine Prevnar 13, said Mike McDermott, the company’s global-supply president.
Yet a single plant doesn’t have capacity to make hundreds of millions of doses by the end of the year, so Pfizer is assembling a network of facilities across the globe that will contribute different steps in the process, Mr. McDermott said.
Pfizer will also hire more workers, he said, and may shift production of existing products to its own facilities or have contract manufacturers temporarily make them to free up capacity.